New Animal Drugs for Investigational Use

Forms and Documents

Document Name	Status
Form 3458 511.1(b)(4) NCIE for clinical investigations Form and Instruction	Modified
Supporting Statement A - 0910-0117.doc Supporting Statement A	2012-06-29

IC Document Collections

IC ID	Document Title	Status
5728	511.1(b)(4) NCIE for clinical investigations Form and Instruction	Modified
203024	511.1(b)(8)(i) - Recordkeeping of investigator reports	New
203023	511.1(b)(7)(ii) - Recordkeeping sponsor	New
203022	511.1(b)(3) - Recordkeeping for clinical investigations	New
203021	511.1(a)(3) - Recordkeeping for laboratory research	New
203020	511.1(b)(9) Import for clinical investigation	New
203019	511.1(b)(8) (ii) Report of significant hazards	New
203018	511.1(b)(6) Information required in order to determine if there are grounds for terminating exemption	New
203017	511.1(b)(5) Data submission for use of edible food products	New

ICR Details

OMB Control No: 0910-0117	ICR Reference No: 201207-0910-001
Status: Historical Active	Previous ICR Reference No: 200806-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: New Animal Drugs for Investigational Use
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/22/2012
	Date Received in OIRA: 07/05/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2015	36 Months From Approved
Responses	5,528	0	0
Time Burden (Hours)	12,328	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: To gain approval to market an animal drug, the applicant must file a New Animal Drug Application containing data to support the safety and effectiveness of the drug, appropriate labeling, product manufacturing information and where applicable, methods to determine residues of the drug in edible tissue from food producing animals.

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Authorizing Statute(s): US Code: 21 USC 512j Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 37814	06/28/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 59140	09/23/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
511.1(b)(4) NCIE for clinical investigations	3458	Notice of Claimed Investigational Exemption
511.1(b)(5) Data submission for use of edible food products
511.1(b)(6) Information required in order to determine if there are grounds for terminating exemption
511.1(b)(8) (ii) Report of significant hazards
511.1(b)(9) Import for clinical investigation
511.1(a)(3) - Recordkeeping for laboratory research
511.1(b)(3) - Recordkeeping for clinical investigations
511.1(b)(7)(ii) - Recordkeeping sponsor
511.1(b)(8)(i) - Recordkeeping of investigator reports

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	5,528	0	0	0	5,524	4
Annual Time Burden (Hours)	12,328	0	0	0	-11,477	23,805
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $472,257,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/05/2012

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